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iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional sui...

FDA Device Recall #Z-0762-2020 — Class II — November 26, 2019

Recall Summary

Recall Number Z-0762-2020
Classification Class II — Moderate risk
Date Initiated November 26, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Deerfield Imaging, Inc.
Location Minnetonka, MN
Product Type Devices
Quantity 6

Product Description

iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room. The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.

Reason for Recall

There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible

Distribution Pattern

CT, MA, VA. International distribution: Australia, Canada, and Qatar.

Lot / Code Information

Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.

Other Recalls from Deerfield Imaging, Inc.

Recall # Classification Product Date
Z-0934-2022 Class II Trumpf Mount Clamp Assembly (table adapter comp... Feb 17, 2022
Z-2586-2021 Class II Operating room table - Product Usage: intended ... Aug 25, 2021
Z-2585-2021 Class II Operating room table - Product Usage: intended ... Aug 25, 2021
Z-2584-2021 Class II Operating room table - Product Usage: intended ... Aug 25, 2021
Z-0163-2020 Class II IMRIS MR/X-ray head fixation device, Model HFD200 Jun 26, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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